RAPS - This course has been pre-approved by RAPS as eligible for up to 2 credits towards a participant's RAC recertification upon full completion.
This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.
Why Should Attend
With the FDA beginning to take a stronger stance on Dietary Supplement enforcement, it is important for companies to verify that their products comply with the latest regulations and provisions.
This 120 minute training will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. We will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An update on FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be discussed.
Dietary Supplement Overview
- What is a dietary supplement?
- Supplements vs. Pharmaceuticals/OTC Drugs/Conventional Foods.
- FDA Structure regarding Dietary Supplements.
- Industry Groups.
History of Dietary Supplement Regulation
- Early History & DSHE.
- Code of Federal Regulations.
- Company & Facility Registration.
- GMP Requirements.
- What qualifies as a dietary ingredient?
- Old dietary ingredients vs. New dietary ingredients.
- New Dietary Ingredient Notification (NDIN).
- Updated New Dietary Ingredient Guidance from FDA.
- Display Panels & Layout.
- Supplement Facts Panel Requirements.
- Labeling Claims.
- Health vs. Disease vs. Structure/Function claims.
- Notification of labeling claims to FDA.
- Dietary Supplement Labeling Act.
- FDA vs. FTC jurisdiction & enforcement.
- Expressed vs. Implied Claims.
- Disclosures & Claim Substantiation.
Questions & Answers.
Who will benefit
This course will be beneficial to the following personnel in Dietary Supplement manufacturing companies:
- Executives of Dietary Supplement companies
- Regulatory Compliance Professionals
- Quality Assurance Professionals
- Dietary Supplement Manufacturers
- Dietary Supplement Distributors
- Sales/Marketing Personnel